Humidity Strategy to Decrease Morbidity and Mortality in Extremely Low Birth Weight Infants

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

700 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-31

Study Completion Date

2010-04-30

Brief Summary

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The purpose of this study is to apply a different incubator humidity strategy at birth to decrease morbidity and mortality in extremely low birth (1000 g or less) infants.

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Detailed Description

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Conditions

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Extremely Low Birth Weight

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Moderate Humidity (MH)

Group Type ACTIVE_COMPARATOR

Moderate Humidity

Intervention Type OTHER

Moderate Humidity Level

High Humidity

Group Type EXPERIMENTAL

High Humidity (HH)

Intervention Type OTHER

High Humidity Level

Interventions

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High Humidity (HH)

High Humidity Level

Intervention Type OTHER

Moderate Humidity

Moderate Humidity Level

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Inborn Premature Infants with weight ≤ 1000 g at birth

Exclusion Criteria

* Outborn infants.
* Failure to obtain parental consent for the study.
* Congenital malformations likely to affect life expectancy or neurosensory development.
* Unlikely to be available for follow up.

Eligible Sex

ALL

Accepts Healthy Volunteers

No